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16 Articles in Volume 20, Issue #5
20/20 with Drs. Carmen R. Green and Johnathan Goree: Racial Disparities in Pain Care
A Kratom Primer: Miracle Medicine or Herb of Abuse?
A Pilot Study: Incidence and Prediction of Diversion among Opioid Therapy Patients
Analgesics of the Future: G-Protein Biased Mu-Opioid Receptor Ligands
Application Note: Decellularized Human Placenta in the Treatment of Infracalcaneal Heel Pain
Are Clinicians Effectively Counseling Patients on Safe Opioid Storage and Disposal? Survey Results
Ask the PharmD: How to Manage Pain Meds During Pregnancy?
Behavioral Medicine: Managing Anxiety and Maladaptive Behaviors
Case Report: Spinal Cord Stimulation for the Treatment of Pain Associated with Chronic Pancreatitis
Differential Diagnoses: Inflammatory or Non-inflammatory Chronic Back Pain?
Pelvic Inflammatory Disease: Diagnosis, Education, and Treatment Options
Product Review: Non-Invasive Neuromodulation for the Treatment of the Most Difficult Pain Conditions
Provider Perspective: Carpal Tunnel's Association with Hypothyroidism
Research Insights: Opioid Use During the Peripartum Period – What to Expect
Special Report: Race, Pain Management, and the System
When Patients Become Pregnant: How to Maintain Chronic Pain Management

Application Note: Decellularized Human Placenta in the Treatment of Infracalcaneal Heel Pain

In a retrospective review of patients with plantar fasciitis, all experienced significant pain reduction after injection with this human connective tissue matrix.

Introduction

Infracalcaneal heel pain is a common podiatric condition presenting as plantar fasciitis, an acute inflammation of the plantar fascial band. Plantar fasciitis is caused by mechanical overload and excessive strain on the plantar fascia secondary to pronation, a high arched foot, and equinus. Despite the belief that the etiology of the condition is the presence of an infracalcaneal heel spur, the true etiology of the condition is soft tissue inflammation.

The incidence and prevalence of plantar heel pain are uncertain. However, it has been estimated that 7% of people over age 65 years in the US report tenderness in the region of the heel, and that plantar heel pain accounts for one-quarter of all foot injuries relating to running.1 In the North West Adelaide Health Study, a population-based study of 3,206 individuals aged 20 years or older, about 4% of the sample indicated that they had pain underneath their heel.2 A further study from the United Kingdom that collected data from 12 primary care settings found that plantar fasciitis accounted for about 8% of musculoskeletal (MSK) foot and ankle consultations in general practice.3 In the US from 1995 to 2000, the diagnosis and treatment of plantar heel pain accounted for more than 1 million visits per year to physicians.4 The condition affects both athletic and sedentary people and does not seem to be influenced by sex.

Conservative treatment for plantar fasciitis includes rest, ice, shoe modification, foot orthotics, night splints, stretching, corticosteroid injections, physical therapy, and platelet-rich plasma (PRP) injections. Data show that PRP injections can provide relief from pain.5,6 Corticosteroid overuse may lead to permanent adverse changes within the joint and surrounding soft tissue structures. Surgical options may include extracorporeal shockwave therapy and plantar fasciotomy.6,7

Diagnosis and treatment of plantar heel pain accounts for more than 1 million US physician visits per year. (Image: iStock)

Interfyl, by Celularity Inc, is an FDA approved human connective tissue matrix from normal, healthy full-term pregnancies intended for use as the replacement or supplementation of damaged or inadequate integumental tissue.An FDA Request for Designation (RFD, file 2004.046) states that allogeneic decellularized human placental connective tissue matrix consists of collagen types 1, 3, 4, and elastin. Other components include lamin, fibronectin, glycosaminoglycan, and water. The tissues are lyophilized and formulated for use as injectable particulate connective tissue matrix.  

Decellularized human placental connective tissue matrix possesses both structural and biochemical properties of the extracellular matrix to provide the framework for cellular components to repair the damaged fibrocytes of plantar fascia tissue and promote growth and tissue repair.6,8 Hence, the ability to inject the healing properties of dehydrated human placenta tissue into the plantar fascia allows for improved treatment and healing of the deeper soft tissue injuries and inflammation.

This retrospective chart review of 32 feet (representing one or two feet each of 19 patients) with plantar fasciitis examines the efficacy of decellularized human placenta for the treatment of infracalcaneal heel pain when conservative therapy alone failed.

Publication Review Committee approval was obtained prior to submission of this case review. 

 

Retrospective Review of Plantar Fasciitis Treated with Decellularized Human Placenta

Materials and Methods

Private practice patients in Illinois from June 2018 until September 2019 were selected for the chart review. Patients included received conservative treatment consisting of rest, ice, compression, corticosteroid injections, stretching exercises, NSAIDs, and orthotics for up to 8 months with little to no pain relief as measured on the Wong-Baker FACES Pain Scale. Patients were excluded if they had prior surgery at the injection or joint site, clinical signs of infection, prior treatment with tissue-engineered material, presence of foot and ankle orthopedic comorbidities such as a foot or ankle stress fracture, known nerve entrapment syndrome, and neurological disease of the lower extremity.

Nineteen adult patients with a clinical diagnosis of plantar fasciitis met inclusion criteria for the chart review. In these patients, a total of 32 feet with plantar fascia were injected. The patient population consisted of 8 males and 11 females with a mean age of 50 years, with the age range from 28 years to 67 years. There were seven patients with bilateral plantar fasciitis and 12 with unilateral plantar fasciitis. Six patients received two unilateral injections that were administered 2 weeks from the initial injection (three were left side, three were right side) because of pain, and continued inflammation of the plantar fascia was observed on ultrasound.

The plantar fascia bands were evaluated using a linear 7.0-MHz ultrasound transducer (Acuson 128XT) (see Figures 1 and 2). During ultrasonography, patients verbalized the absence or presence of pain in the affected area when the plantar fascia bands were palpated. Ultrasonographic examinations were initially performed with patients positioned prone, and feet hanging over the edge of the examination table. The medial, central, and lateral aspects of the heel at the insertion of the plantar fascia were palpated to determine the location of the corresponding bands. A bead of the acoustic gel was applied to the cover of the head of the transducer, which was then placed longitudinally on the plantar aspect of the foot.

Figure 1. Ultrasound longitudinal view of symptomatic inflamed medial band of plantar fascia at its proximal origin.Figure 2Figure 2. Ultrasound longitudinal view of asymptomatic non-inflamed medial band of plantar fascia at its proximal origin.

The focus was adjusted to the depth of the plantar fascia at its attachment to the calcaneus. Ultrasonographic scanning was performed during dynamic dorsiflexion of the toes to stretch the plantar fascia, allowing its margins to be delineated to locate the symptomatic plantar fascia bands.

After the location of the symptomatic plantar fascia, 1.5 ml of normal saline was used to reconstitute the 1.5 ml of decellularized human placenta for a total of 3.0 mL that was then injected at the site of pain. A T-test was used to compare the pre-injection pain level of the plantar fascia to the pain level at 2 weeks post-injection and pain level at 4 weeks post-injection. BMI was also statistically tested for correlation with post-injection pain levels. See Figures 3 and 4.

 

Results

Data from the 19 patients (32 feet) with refractory plantar fasciitis following injection of decellularized human placenta at 2 weeks and 4 weeks were analyzed. A T-test was used to examine the following:

  • statistical significance between pain level before the first decellularized human placenta injection and pain level at 2 weeks post-injection (P = 1.47 x 10-16). See Figure 3.
  • statistical significance between pain level prior to the first injection and pain level at 4 weeks post-injection (P = 3.39 x 10-21). See Figure 4.
  • statistical significance between pain level at 2 weeks and 4 weeks post-injection of decellularized human placenta (P = 7 x 10-7). A positive correlation was also found between patients with a higher BMI and a greater degree of pain reduction with Interfyl injections at 4 weeks post-injection.

Figure 3Figure 3. Comparison of pain levels before the first injection and 2 weeks after injection.Figure 4Figure 4. Comparison of pain levels before the first injection and at 4 weeks.

 

Discussion: Placental Extracts in Medical Use

Historically, placental extracts have been used for the treatment of a variety of pathological conditions, most commonly in surgery, neurology, gynecology, and dermatology. Placental extracts have been shown to enhance the proliferation of fibroblasts and reduce the concentration of free radicals, inflammatory cytokines IL-6, TNF, and IL-1 and at the same time increase the formation of progenitor cells and reduce oxidative damage to the cells.9-11

Analysis of the biosafety of placental extracts revealed the absence of toxic or mutagenic influence on cultures.12 Positive effects were realized with the treatment of wounds and pain reduction.8,9,10

For plantar fasciitis, the authors had noted a reported a case where surgical implantation of human placental membrane was successful in treating recalcitrant plantar fasciitis in a patient who failed conservative and surgical treatment. The patient was able to return to full activities of daily living.13   We wanted to determine similar effects of preserved decellularized human placenta when treating recalcitrant plantar fasciitis pain.

While decellularized human placenta is proving to have promising implications in treating patients with recalcitrant plantar fasciitis pain, looking ahead long-term prospective studies with a greater patient pool are needed to better assess its use within current treatment guidelines, such as those from the American College of Foot and Ankle Surgeons.

Of note, obesity has been identified as a cause of plantar fasciitis in up to 70% of patients and should be a factor to evaluate in the treatment of plantar fasciitis.14 There are many possible treatments for plantar fasciitis pain, however, no single treatment can be guaranteed based on the quality of life measures that include comorbidities (arthritis, obesity, diabetes), medication use, and lifestyle factors (alcohol use, smoking, malnutrition).

Going forward, the authors recommend consideration of decellularized human placenta injections for those patients who fail conservative treatments.

Continue Reading:
Effective Protocol for the Management of Plantar Fasciitis
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